UROLOGIX TARGIS SYSTEM
FDA premarket approval P970008/S053 · decided 2011-01-07
Approval details
- PMA number
- P970008
- Supplement
- S053
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- UROLOGIX TARGIS SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, LLC
- Date received
- 2010-11-16
- Decision date
- 2011-01-07
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR MODIFICATION OF THE CTC ADVANCE MICROWAVE TREATMENT CATHETER TO INCORPORATE AN ADDITIONAL SET OF COOLANT OUTPUT HOLES.
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